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Location:
Wuxi, Jiangsu, China
Job reference: R-039412
Posted date: Nov. 19, 2018
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Responsibilities:

- Lead the validation activity for the process / cleaning validation etc., including: developing the detail validation strategy & approach, and validation / experimental data analysis under some statistical tools if necessary

- Investigate any issues encountered during routine production; provide a technical evaluation of the issue, conduct any studies required to provide supporting evidence and lead any required changes to the process / product

- Perform an ongoing review of the process and products to identify any trends / signals and take appropriate actions to ensure the process stays in control

- Identify opportunities for improvement/lean in the production process / review others ideas for suggested improvements in the production process and implementation of any such changes

- Create / update SOP or Guidelines for the validation principles or to clarify the group standard way of working

- Create / update BPRs

- SAP master date maintain if applicable

- Validation / process development documents e.g. PV, CV etc.

- Manage projects to support site business development, e.g. new product introduction, technical transfer, supply switch over, production line expansion, continuous improvement, etc.

Requirements:

- University graduate or above

- Familiar with the Pharmaceutical knowledge; including production processes

- GMP knowledge

- Familiar with the knowledge of process and cleaning validation

- Excellent written / oral English

- High level of computer skills

- Basic statistical knowledge

- Regulatory knowledge

- At & above the AZ 6 leadership capacity requirement for each level

- A3 report/FEMA, etc. tools used for problem solving

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(Sr.) Process Engineer, Formulation
Manufacturing

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